Drug Recall: 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply
Novocol Pharmaceutical of Canada, Inc. · October 31, 2025
Reason for Recall
Defective container: cracked/broken cartridges
Product Description
2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-176-16.
Distribution
U.S.A. Nationwide
States Affected
NATIONWIDE
Quantity Affected
18,789 cartons- 50 cartridges /carton
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0228-2026
Status: ongoing
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